ONC HTI-1 Prior Authorization Decision Support: Transparency Mandates

The ONC HTI-1 Rule and DSI Transparency

The ONC HTI-1 final rule, building on the 21st Century Cures Act, aims to enhance health IT interoperability and patient access to information. A core component addresses the transparency of DSI, including those powered by artificial intelligence and other advanced algorithms. The rule requires certified health IT modules to enable the display of specific 'source attributes' for DSI that inform clinical care. This mandate applies broadly to any DSI used by a clinician to make patient care decisions.

Defining Decision Support Interventions (DSI)

The ONC defines DSI as technology that provides information, alerts, or recommendations to a user to inform a health-related decision. This definition is broad, encompassing tools ranging from simple drug-drug interaction alerts to complex diagnostic algorithms. For prior authorization, DSI often includes criteria-based prompts, medical necessity guidelines, or payer-specific rules integrated into the EHR workflow. These interventions guide providers in determining the appropriateness of a service before submission.

Mandated Source Attributes for DSI

HTI-1 specifies a set of source attributes that certified health IT must make available to users for each DSI. These attributes provide critical context about the DSI's origin, function, and limitations. EHR systems and integrated third-party CDS solutions must ensure this information is accessible at the point of care. This requirement fosters trust and enables informed use of algorithmic support in clinical decision-making.

Key Source Attributes Required by HTI-1:

• **Developer Name:** The entity responsible for the DSI.
• **DSI Name:** The specific name or identifier of the decision support tool.
• **Version:** The current version number of the DSI.
• **Description:** A concise explanation of what the DSI does.
• **Purpose/Intended Use:** The specific clinical context or problem the DSI aims to address.
• **Data Sources:** The types and origins of data used to train or inform the DSI (e.g., claims data, EHR data, clinical trials).
• **Logic/Methodology:** A high-level explanation of how the DSI arrives at its recommendations or alerts (e.g., rule-based, machine learning model).
• **Evidence Base:** The scientific or clinical evidence supporting the DSI's recommendations.
• **Known Limitations:** Any identified biases, populations for which the DSI is not validated, or scenarios where it may be inaccurate.
• **Risks:** Potential harms or negative consequences associated with using the DSI.
• **Updates:** Information about the frequency and process for DSI updates.
• **Date of Last Update:** The most recent date the DSI was updated or reviewed.
• **Relevant Certifications:** Any other certifications or standards the DSI adheres to.

Prior Authorization Decision Support Implications

The DSI transparency requirements directly impact tools used in prior authorization workflows. Many PA-related CDS functionalities, such as those flagging services requiring PA, suggesting specific CPT codes based on ICD-10 diagnoses, or comparing proposed treatments against MCG/InterQual criteria, fall under the DSI definition. For instance, an EHR module that provides a 'PA required' alert based on payer rules or suggests a specific diagnosis code for a procedure is a DSI. Its source attributes must be available.

Impact on EHRs and Third-Party CDS Vendors

EHR vendors, including Epic Hyperspace and Cerner PowerChart, must ensure their certified modules can present these source attributes. This extends to third-party CDS solutions like CoverMyMeds, Availity, eviCore, or Carelon, which integrate into the EHR to facilitate PA. If these third-party tools function as DSI, their developers must provide the necessary source attribute information to the EHR vendor for display. This requires robust data exchange mechanisms and clear agreements between all parties.

Connecting to Da Vinci PAS and X12 278

The HTI-1 DSI transparency requirements complement initiatives like the Da Vinci Project's Prior Authorization Support (PAS) implementation guides and the X12 278 (HIPAA) transaction. While Da Vinci PAS focuses on FHIR-based real-time PA exchange and the 278 is for traditional PA requests, the underlying medical necessity decisions often rely on DSI. Transparent DSI can strengthen the justification data sent via these standards, potentially reducing denials and accelerating approvals. For example, if a DSI informs the medical necessity criteria used in a Da Vinci PAS query, the transparency of that DSI becomes critical.

Operationalizing DSI Transparency for PA

Implementing DSI transparency for prior authorization involves several operational considerations. Clinical informatics leads and IT integration teams must work closely to identify all PA-touching DSI within their systems. They need to ascertain whether the required source attributes are available from vendors and how they will be presented to clinicians without disrupting workflow. This also includes defining internal processes for reviewing and validating the provided DSI information.

Compliance and Audit Readiness

EHR vendors and health systems should discuss HTI-1 DSI compliance with their regulatory and legal teams. Demonstrating adherence to these transparency mandates will be essential for certification and ongoing operation. This includes maintaining documentation of DSI source attributes, how they are presented, and processes for managing updates. Audit readiness will require clear policies and procedures for DSI management.

Benefits of Enhanced DSI Transparency

Beyond compliance, DSI transparency offers tangible benefits. Clinicians gain a clearer understanding of the algorithmic basis for PA decisions, fostering greater trust in the tools they use. This insight can also improve peer-to-peer (P2P) discussions by providing a common ground for discussing medical necessity criteria. Ultimately, better-informed PA submissions, supported by transparent DSI, can lead to more efficient revenue cycle operations and improved patient access to care. See how Klivira is supporting advanced prior authorization automation at our /use-cases/prior-authorization-automation page.